PlainRecalls
FDA Drug Moderate Class II Terminated

Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40

Reported: December 29, 2021 Initiated: August 3, 2021 #D-0289-2022

Product Description

Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40

Reason for Recall

Failed Impurities/Degradation Specifications

Details

Recalling Firm
The Harvard Drug Group
Units Affected
2,239 bottles
Distribution
Nationwide USA
Location
Livonia, MI

Frequently Asked Questions

What product was recalled?
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40. Recalled by The Harvard Drug Group. Units affected: 2,239 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on December 29, 2021. Severity: Moderate. Recall number: D-0289-2022.